The purpose of this study is to determine the recommended phase 2 dose(s) (RP2Ds) of JNJ-78278343 in Part 1 (Dose Escalation) and the safety at the RP2Ds in Part 2 (Dose Expansion).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
216
JNJ-78278343 will be administered.
Columbia University Medical Center Herbert Irving Pavilion
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Part 1 and 2: Number of Participants With Adverse Events (AEs)
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/ biological agent under study.
Time frame: Up to 1 year and 10 months
Part 1 and 2: Number of Participants With AEs by Severity
Severity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0. Severity scale ranges from Grade 1 (Mild) to Grade 5 (Death). Grade 1= Mild, Grade 2= Moderate, Grade 3= Severe, Grade 4= Life-threatening and Grade 5= Death related to adverse event. Cytokine release syndrome (CRS) and immune effector cell associated neurotoxicity syndrome (ICANS) will be graded according to the American Society for Transplantation and Cellular Therapy (ASTCT) guidelines.
Time frame: Up to 1 year and 10 months
Part 1: Number of Participants With Dose-Limiting Toxicity (DLT)
Number of participants with DLT will be reported. The DLTs are specific adverse events and are defined as any of the following: high grade non-hematologic toxicity, or hematologic toxicity.
Time frame: Up to 1 year and 10 months
Serum Concentration of JNJ-78278343
Serum concentrations of JNJ-78278343 will be determined.
Time frame: Up to 1 year and 10 months
Systemic Cytokine Concentrations
Cytokine concentrations will be determined for biomarker assessment.
Time frame: Up to 1 year and 10 months
Serum Prostate Specific Antigen (PSA) Concentration
Serum PSA concentration will be measured.
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University of Washington
Seattle, Washington, United States
Peking University Third Hospital
Beijing, China
Chongqing University Cancer Hospital
Chongqing, China
Sun Yat Sen University Cancer Center
Guangzhou, China
First Affiliated Hospital Of Wenzhou Medical College
Wenzhou, China
Centre Leon Berard
Lyon, France
APHM Hopital Timone
Marseille, France
Institut Gustave Roussy
Villejuif, France
...and 7 more locations
Time frame: Up to 1 year and 10 months
Number of Participants With Anti-JNJ-78278343 Antibodies
Serum samples will be analyzed for the detection of anti-JNJ-78278343 antibodies using a validated assay method.
Time frame: Up to 1 year and 10 months
Objective Response Rate (ORR)
ORR is defined as the percentage of participants who have a partial response (PR) or better according to the response evaluation criteria in solid tumors (RECIST) version 1.1 response criteria without evidence of bone progression according to prostate cancer working group 3 (PCWG3).
Time frame: Up to 1 year and 10 months
Radiographic Progression-free Survival (rPFS)
rPFS is defined as time from the date of first dose of JNJ-78278343 until the date of objective disease progression or death, whichever comes first.
Time frame: Up to 1 year and 10 months
PSA Response Rate
PSA response rate is defined as the percentage of participants with a decline of PSA of 50 percent (%) or more from baseline. The maximum reduction from baseline in PSA will also be calculated during the treatment.
Time frame: Up to 1 year and 10 months
Duration of Response (DOR)
DOR will be calculated among responders (PR or better) from the date of initial documentation of a response (PR or better) to the date of first documented evidence of progressive disease, as defined in the PCWG3 or RECIST version 1.1 response criteria, or death due to any cause, whichever occurs first.
Time frame: Up to 1 year and 10 months